Quality Engineer

Operating Company: Spark Location: Mexicali, Baja California, MX Date Posted: July 23, 2024 Req Number: R5020424Job Description:Review new and modified processes.Analysis for validation or revalidation requirements (IQ/OQ/PQ).Validation protocols creation.Validations tracking.Support on validation corrective actions required.Report validation results.Statistical support on production processes:Required SPC tool evaluation.Report validation results.Capability studies implementation.Gage R&R implementation.Support to implement methods/alternative sampling.Support to eliminate destructive tests.Support to improvement projects.Job Requirements:Industrial Engineer, Mechanical Engineer, Electronics Engineer, or similar.Medical Industry experience.QMS and ISO Standard knowledge (ISO13485 and/or FDA GMP).3 years of manufacturing process experience.Experience in new product development, process transfers, and process improvement.English proficiency at about 85% (spoken, written, read).#J-18808-Ljbffr